Acupuncture for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome : A Pilot Randomized Clinical Trial

Importance: Acupuncture is a promising therapy for irritable bowel syndrome (IBS), but the use of subjective scales as an assessment is accompanied by high placebo response rates.

Objectives: To preliminarily test the feasibility of using US Food and Drug Administration (FDA)-recommended end points to evaluate the efficacy of acupuncture in the treatment of IBS.

Design, Setting, and Participants: This pilot, multicenter randomized clinical trial was conducted in 4 tertiary hospitals in China from July 1, 2020, to March 31, 2021, and 14-week data collection was completed in March 2021. Individuals with a diagnosis of IBS with diarrhea (IBS-D) were randomized to 1 of 3 groups, including 2 acupuncture groups (specific acupoints [SA] and nonspecific acupoints [NSA]) and a sham acupuncture group (non-acupoints [NA]) with a 1:1:1 ratio.

Interventions: Patients in all groups received twelve 30-minute sessions over 4 consecutive weeks at 3 sessions per week (ideally every other day).

Main Outcomes and Measures: The primary outcome was the response rate at week 4, which was defined as the proportion of patients whose worst abdominal pain score (score range, 0-10, with 0 indicating no pain and 10 indicating unbearable severe pain) decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater.

Results: Ninety patients (54 male [60.0%]; mean [SD] age, 34.5 [11.3] years) were enrolled, with 30 patients in each group. There were substantial improvements in the primary outcomes for all groups (composite response rates of 46.7% [95% CI, 28.8%-65.4%] in the SA group, 46.7% [95% CI, 28.8%-65.4%] in the NSA group, and 26.7% [95% CI, 13.0%-46.2%] in the NA group), although the difference between them was not statistically significant (P = .18). The response rates of adequate relief at week 4 were 64.3% (95% CI, 44.1%-80.7%) in the SA group, 62.1% (95% CI, 42.4%-78.7%) in the NSA group, and 55.2% (95% CI, 36.0%-73.0%) in the NA group (P = .76). Adverse events were reported in 2 patients (6.7%) in the SA group and 3 patients (10%) in NSA or NA group.

Conclusions and Relevance: In this pilot randomized clinical trial, acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups. These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy.

Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000030670.

Medienart:	E-Artikel

Erscheinungsjahr:	2022
Erschienen:	2022

Enthalten in:	Zur Gesamtaufnahme - volume:5
Enthalten in:	JAMA network open - 5(2022), 12 vom: 01. Dez., Seite e2248817

Sprache:	Englisch

Beteiligte Personen:	Qi, Ling-Yu [VerfasserIn] Yang, Jing-Wen [VerfasserIn] Yan, Shi-Yan [VerfasserIn] Tu, Jian-Feng [VerfasserIn] She, Yan-Fen [VerfasserIn] Li, Ying [VerfasserIn] Chi, Li-Li [VerfasserIn] Wu, Bang-Qi [VerfasserIn] Liu, Cun-Zhi [VerfasserIn]

Links:	Volltext

Themen:	Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Anmerkungen:	Date Completed 02.01.2023 Date Revised 04.02.2023 published: Electronic ChiCTR: ChiCTR2000030670 Citation Status MEDLINE

doi:	10.1001/jamanetworkopen.2022.48817

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	NLM350917019